FDA Adverse Event
Malfunction
Summary report: N
KYPHX BONE BIOPSY DEVICE
MDR report key: 1222852
·
Received November 6, 2008
Report
- Report Number
- 2953769-2008-00055
- Event Type
- Malfunction
- Date Received
- November 6, 2008
- Date of Event
- September 12, 2008
- Report Date
- September 12, 2008
- Manufacturer
- MEDTRONIC SPINE LLC.
- Product Code
- KNW
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD - OTHER; FOLLOW UP CONVERSATION WITH COMPANY REPRESENTATIVE. RESULTS - OTHER; NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
DURING A KYPHOPLASTY PROCEDURE, IT WAS REPORTED THAT THE PLASTIC HANDLE OF THE BIOPSY NEEDLE CAME OFF WHEN THE SURGEON TRIED REMOVING IT FROM THE PT. AFTER APPROXIMATELY 90 MINS TRYING TO REMOVE THE NEEDLE, THE SURGEON BROKE IT OFF AT THE PEDICLE LEVEL AND DRILLED OUT THE NEEDLE PORTION THAT REMAINED IN THE PEDICLE. A PORTION OF THE NEEDLE REMAINS IN THE PT'S VERTEBRAL BODY. PER THE REPORT, THERE WAS NO INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KYPHX BONE BIOPSY DEVICE | BONE BIOPSY DEVICE | KNW | MEDTRONIC SPINE LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |